Esomeprazole Aristo 40 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Esomeprazol Aristo 40 mg gastro-resistant hard capsules EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Esomeprazol Aristo is and what it is used for

2. What you need to know before taking Esomeprazol Aristo

3. How to take Esomeprazol Aristo

4. Possible side effects

5. How to store Esomeprazol Aristo

6. Contents of the pack and other information

1. What Esomeprazol Aristo is and what it is used for

Esomeprazol Aristo contains a medicine called esomeprazole which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazole is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole may also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcers initially treated with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol Aristo

Do not take Esomeprazol Aristo

• if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you are taking a medicine containing nelfinavir (used to treat HIV infection),
• if you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

If any of these apply to you, do not take esomeprazole. If you are unsure, consult your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking esomeprazole

• if you have severe liver problems;
• if you have severe kidney problems;
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazole used to reduce stomach acid. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with esomeprazole treatment. Stop taking esomeprazole and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4;
• if you are scheduled for a specific blood test (Chromogranin A).

Esomeprazole may mask symptoms of other conditions. Therefore, if you experience any of the following events before starting or while taking esomeprazole, contact your doctor immediately:

• You lose a lot of weight without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

If you have been prescribed esomeprazole "on-demand" (only when you notice symptoms), you should contact your doctor if your symptoms persist or change.

If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Taking a proton pump inhibitor such as esomeprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with esomeprazole may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may include mouth, throat, nose, or genital ulcers and conjunctivitis (red, swollen eyes). These serious skin rashes usually appear after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blistering and skin peeling.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

Esomeprazole is not recommended for children under 12 years of age.

Other medicines and Esomeprazol Aristo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because esomeprazole may affect how some medicines work, and some medicines may influence the effect of esomeprazole.

Do not take esomeprazole capsules if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, or clomipramine (for treatment of depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking esomeprazole.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses for cancer treatment); if you are taking a high dose of methotrexate, your doctor may temporarily stop your esomeprazole treatment.
• Tacrolimus (organ transplant).
• Rifampicin (used to treat tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to esomeprazole to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol Aristo with food and drink

You may take the capsules with food or on an empty stomach.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will decide whether you can take esomeprazole during this period.

It is unknown whether esomeprazole passes into breast milk. Therefore, esomeprazole should not be taken during breastfeeding.

Driving and using machines

Esomeprazole is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or use machines if you experience any of these effects.

Esomeprazol Aristo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; essentially “sodium-free”.

3. How to take Esomeprazol Aristo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many capsules you should take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are detailed below.

Use in adults from 18 years of age

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your oesophagus is slightly affected, the recommended dose is one 40 mg esomeprazole capsule once daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once the oesophagus has healed, the recommended dose is one 20 mg esomeprazole capsule once daily.
• If your oesophagus is not affected, the recommended dose is one 20 mg esomeprazole capsule per day. Once your condition has been controlled, your doctor may instruct you to take the medicine only when needed, up to a maximum of one 20 mg esomeprazole capsule per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg esomeprazole capsule twice daily for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole capsule once daily for 4–8 weeks.

For the prevention of gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole capsule once daily.

For the treatment of excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg esomeprazole capsule twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment for prevention of rebleeding from peptic ulcer initiated with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole capsule once daily for 4 weeks.

Use in adolescents from 12 years of age

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your oesophagus is slightly affected, the recommended dose is one 40 mg esomeprazole capsule once daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once the oesophagus has healed, the recommended dose is one 20 mg esomeprazole capsule once daily.
• If your oesophagus is not affected, the recommended dose is one 20 mg esomeprazole capsule per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg esomeprazole capsule twice daily for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

How to take this medicine

• You may take the capsules at any time of day.
• You may take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain coated granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and disperse the contents in half a glass of still (non-carbonated) water. Do not use other liquids.
• Shake the mixture and drink it immediately or within the next 30 minutes. Always shake the mixture just before drinking. The solution will not be clear.
• To ensure you have taken all the medicine, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine; do not chew or crush the granules.
• If you are unable to swallow at all, the pellets may be dispersed in still water and drawn into a syringe. They can then be administered directly into the stomach via a tube (gastric tube).

Use in children under 12 years of age

Esomeprazole is not recommended for children under 12 years of age.

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Aristo than you should

If you take more esomeprazole than your doctor has prescribed, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Esomeprazol Aristo

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop taking esomeprazole and contact a doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.

• Sudden difficulty breathing, swelling of the lips, tongue and throat or the whole body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. These effects are very rare and may affect up to 1 in 10,000 people.

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other adverse effects include:

Common: may affect up to 1 in 10 people

• Headache.
• Stomach or intestinal effects: diarrhoea, stomach pain, constipation, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon: may affect up to 1 in 100 people

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling and numbness sensations, drowsiness.
• Dizziness (vertigo).
• Dry mouth.
• Abnormal liver function blood tests.
• Skin rash, hives, itching.
• Fracture of the hip, wrist, or spine (if esomeprazole is used at high doses and for a prolonged period).

Rare: may affect up to 1 in 1,000 people

• Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the oesophagus.
• Liver problems including jaundice, which may cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis triggered by exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

Very rare: may affect up to 1 in 10,000 people

• Changes in blood cell counts, including agranulocytosis (reduction in white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Breast enlargement in men.

Frequency not known: frequency cannot be estimated from available data

• Inflammation of the intestine (which may lead to diarrhoea).
• Skin rash, possibly with joint pain.
• Low magnesium levels in blood (hypomagnesaemia) (see section 2 “Warnings and precautions”).

In very rare cases, esomeprazole may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about any medication you are currently taking.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Aristo

• Keep this medicine out of the sight and reach of children.

• Do not store above 25°C.

• Store in the original packaging (blister) or keep the container (bottle) tightly closed to protect from moisture.

• Do not use this medicine after the expiry date stated on the packaging, blister, or bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Aristo gastro-resistant capsules

• The active substance is esomeprazole.

There are two different strengths of Esomeprazol Aristo gastro-resistant capsules containing 20 mg or 40 mg of esomeprazole (as magnesium salt dihydrate).

• The other components are:

Capsule contents

Granules: carrageenan, microcrystalline cellulose, mannitol, sodium hydroxide, sodium hydrogen carbonate

Isolating coating: polyethylene glycol-polyvinyl alcohol copolymer, sodium hydroxide, talc, titanium dioxide (E171), colloidal hydrated silica

Gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, titanium dioxide (E171)

Capsule

Cap: gelatin, iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172)

Body: gelatin, titanium dioxide (E171)

Appearance of the product and pack contents

Esomeprazol Aristo 40 mg gastro-resistant hard capsules

Capsule with an opaque white body and an opaque orange cap, containing gastro-resistant granules that are white or almost white.

The capsules are supplied in high-density polyethylene bottles with a desiccant capsule and a polypropylene cap, or in aluminium/aluminium blisters. Do not ingest the desiccant capsule included in the bottle.

Pack sizes:

14, 28 and 56 capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid, Spain

Manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Esogasec 40 mg magensaftresistente Hartkapseln

Poland: Esogasec

Spain: Esomeprazol Aristo 40 mg cápsulas duras gastrorresistentes EFG

France: ESOMEPRAZOLE EVOLUGEN PHARMA 40 mg, gélule gastro-résistante

Portugal: Esomeprazol Aristo 40 mg cápsulas gastrorresistentes

Date of the most recent review of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

For patients with swallowing difficulties, the capsules can be opened and the pellets mixed with still water for administration via a gastric tube. It is important to carefully check the suitability of the selected syringe and tube.

Administration via gastric tube

The pellets should be administered using a gastric tube with a minimum diameter of FR15 and lateral outlet. After dispersion in still water, the pellets must be administered immediately.

Administration via gastric tube must not take longer than 5 minutes.

1. Open the capsule and empty the pellets into a suitable syringe. Fill the syringe with approximately 25 ml of water and about 5 ml of air. For some tubes, dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe to distribute the granules evenly throughout the suspension.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).
6. Reposition the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube.

Repeat this process until the syringe is empty.

1. Refill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any remaining residue from the syringe. For some tubes, 50 ml of water may be required.